NEW YORK – The UK's National Institute for Health and Care Excellence (NICE) on Thursday recommended two autologous CAR T-cell therapies, Gilead's Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel), for inclusion in the Cancer Drugs Fund.
Within the Cancer Drugs Fund, NICE and the National Health Service England will work with Gilead to collect additional data about the effectiveness of the treatments. Yescarta will be available to patients with diffuse large B‑cell lymphoma as a second-line treatment after they've become refractory or resistant to chemo-immunotherapy. Tecartus will be available to relapsed or refractory B-cell acute lymphoblastic leukemia patients who are at least 26 years old.
In a November draft guidance, NICE recommended against routine Yescarta use as a second-line treatment for diffuse large B‑cell lymphoma. The institute cited uncertainty in the long-term efficacy of the drug and differences in standard treatments received by patients in the trial and within NHS practice. NICE also said in the guidance that the list price for Yescarta is £280,451 ($349,451) for one infusion, which made cost-effectiveness estimates higher than what was acceptable with the NHS.
In December, NICE also issued a draft guidance that recommended against routine Tecartus use for patients with relapsed or refractory B-cell acute lymphoblastic leukemia. NICE said there was uncertainty about the effectiveness of Tecartus because Gilead submitted data from a trial in which it did not compare the therapy against another treatment. In this case, NICE again said cost-effectiveness estimates were higher than what is normally considered an acceptable use of NHS resources, noting that Tecartus' list price is £316,118 ($393,894) for one infusion.
NICE aims to collect additional data on both drugs to address uncertainties on how well the treatments work over a longer period and whether the results are generalizable to NHS practice. Data will be collected over four years through the Cancer Drugs Fund, based on which NICE will update its guidance on these drugs. During this time, the drugs will be available to the NHS at a discount through a managed access agreement with Gilead.
"Around 1,000 people [per year] in total could benefit from a range of different CAR-T therapies, including these latest treatments, which have all been recommended by NICE in recent months," Helen Knight, director of medicines evaluation at NICE, said in a statement. "We are committed to constantly learning from data and implementation, so patients can benefit from ground-breaking treatments while more information is gathered, which will hopefully lead to them being offered routinely on the NHS in the future."
In January, NICE recommended Yescarta as a third-line treatment for relapsed or refractory diffuse large B-cell lymphoma. Last year, the European Commission also approved Yescarta as a second-line treatment for patients with relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphoma. Yescarta is also approved in the second-line setting for diffuse large B-cell lymphoma in the US.
NICE previously recommended Tecartus for relapsed or refractory mantle cell lymphoma through the Cancer Drugs Fund. The European Medicine Agency's Committee for Medicinal Products for Human Use recommended the treatment for relapsed or refractory B-cell precursor acute lymphoblastic leukemia last year. Tecartus is also approved in the US for mantle cell lymphoma and acute lymphoblastic leukemia.